Renagel(sevelamer)
Renagel, Renvela, Tasermity (sevelamer) is a small molecule pharmaceutical. Sevelamer was first approved as Renagel on 1998-10-30. It is used to treat hyperphosphatemia in the USA. It has been approved in Europe to treat hyperphosphatemia and renal dialysis.
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Commercial
Trade Name
FDA
EMA
Renagel, Renvela (generic drugs available since 2017-06-13)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| renagel | New Drug Application | 2020-04-30 |
| renvela | New Drug Application | 2021-07-15 |
| sevelamer hydrochloride | ANDA | 2023-06-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hyperphosphatemia | HP_0002905 | D054559 | — |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
83 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | N18 | 1 | 8 | 15 | 4 | 3 | 31 | |
| Hyperphosphatemia | D054559 | HP_0002905 | 2 | 3 | 12 | 2 | 5 | 24 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | 3 | 7 | 1 | 2 | 14 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | 3 | 1 | 1 | 5 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | 1 | — | 1 | 2 | 4 | |
| Arteriosclerosis | D001161 | EFO_0009086 | I70 | — | — | — | 1 | — | 1 |
| Calcinosis | D002114 | — | — | — | 1 | — | 1 | ||
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | 2 | — | 1 | 4 |
| Dialysis | D003956 | — | — | 1 | — | 1 | 2 | ||
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | — | — | 1 | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
| Peritoneal dialysis | D010530 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | — | 2 | — | — | 1 | 3 | |
| Diabetic nephropathies | D003928 | EFO_0000401 | 1 | 1 | — | — | — | 2 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | — | — | 1 | 2 |
| Chronic kidney disease-mineral and bone disorder | D012080 | EFO_1001152 | N25.0 | — | 1 | — | — | — | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | 1 | — | — | — | 1 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | — | 4 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 3 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | — | 1 | 1 |
| Familial hypophosphatemia | D007015 | E83.31 | — | — | — | — | 1 | 1 | |
| Rickets | D012279 | EFO_0005583 | E55.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SEVELAMER |
| INN | sevelamer |
| Description | Sevelamer (rINN) is a phosphate binding medication used to treat hyperphosphatemia in patients with chronic kidney disease. When taken with meals, it binds to dietary phosphate and prevents its absorption. Sevelamer was invented and developed by GelTex Pharmaceuticals. Sevelamer is marketed by Sanofi under the brand names Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate).
|
| Classification | Small molecule |
| Drug class | polymers |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C=CCN.ClCC1CO1 |
Identifiers
| PDB | — |
| CAS-ID | 52757-95-6 |
| RxCUI | 214824 |
| ChEMBL ID | CHEMBL1201798 |
| ChEBI ID | — |
| PubChem CID | 3085017 |
| DrugBank | DB00658 |
| UNII ID | 941N5DUU5C (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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444 adverse events reported
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